Observing Oxygen Therapy Alongside Standard Care in Heart Attack Patients

Trial details

Who runs it

TherOx

Trial code

NCT06438315

Record updated

2 November 2026

Original description

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.Read full original descriptionShow less

SuperSaturated Oxygen Comprehensive Observational Registry

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.

Exclusion: Currently participating in an interventional drug or device trial; Non-MRI compatible cardiac pacemaker or implantable defibrillator; Non-MRI compatible aneurysm clip or other metallic implants; Neural Stimulator (i.e., TENS unit); Any implanted or magnetically activated device (insulin pump); Any type of non-MRI compatible ear implant; Metal shavings in the orbits; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for >15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast; Subjects will be excluded if they meet any of the following criteria:; Life expectancy of less than 2 years; No access to medical records from either the index hospitalization or subsequent outpatient visits; cMRI Sub-Study; At qualifying sites that can perform cMRI scans, subjects who meet the following inclusion and exclusion criteria will be considered for the cMRI sub-study; cMRI Inclusion Criteria; Subjects will be included in the cMRI sub-study must meet all these criteria:; Meet all the inclusion and exclusion criteria for the overall study; Consent during index hospitalization to participate in the main study; cMRI Exclusion Criteria; Subjects will be excluded from the sub-study if they are contraindicated to MRI, including any of the following:.

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label) Cohorts must meet ALL the following baseline criteria:; Patients must be ≥ 18 years and ≤ 80 years of age; Presentation with AMI and successful revascularization of the infarct-related artery with PCI; The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB); Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study; Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria:; The primary culprit lesion must be in the left anterior descending (LAD) coronary artery; Successful primary PCI within 6 hours of symptom onset (defined as persistent symptoms that caused the patient to pursue medical care), as documented by <50% diameter residual angiographic stenosis and Thrombolysis In Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel; No major complications such as presence of post-PCI dissection or perforation, serious bleeding, presence of cardiogenic shock (including the use of intra-aortic balloon pump (IABP) or mechanical circulatory support (MCS)) before the end of PCI procedure; Not pregnant or nursing.

ClinicalTrials.gov NCT06438315